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Hopefully John Reader in on the case and liaising with the review board of the GOOD LABORATORY PRACTICE for MHRA clarification. There was a case with 1802 patient once if I’m not mistaken where they found it difficult to understand the molecules requested for product protection. Could be the same here, new invention and all that just needs a helping hand to see what they are up against with a new approach to tackling Autoimmune Disease? Here hoping again!
1 share traded hopefully RNS stating problem solved CTA approval x 1 was traded Tuesday afternoon before the out of hours RNS here’s hoping GLA
Clarification of toxicology report then maybe???
I don’t suppose the use of the word resubmission means the process will have to started again?? It just could be some clarification between the CONTRACT RESEARCH ORGANISATION (CRO) Sareum has used and GOOD LABORATORY PRACTICE? Here’s hoping the issue is resolved quickly and we can get on our merry way gla
Would of been prudent to suspend trading until issue resolved?
Suspend the shares until queries answered,, best post num4 excellent hope they do
Sareum’s website has no indication of compliance to the GOOD LABORATORY PRACTICE or any affiliation to any governing body find it strange being in the business they are in??? More questions need answering
It seems to me they weren’t a part of the club just wondering if sareum has complied to this??? Obviously it’s the facility’s where they have been carrying out there work or a part maybe some carried out in US we need more info… it was ok SAR737 strange it’s not ok now
The test facility must belong to the UK GLP compliance monitoring programme, run by the UK GLP Monitoring Authority (UK GLPMA). The programme is only open to facilities in the UK.
Test facilities that are contracted to work on part of a larger regulatory study should also usually be members of the compliance programme.
Maybe just a simple compliance thing that needs clarification ie FDA approval of Bristols TYK2.. Heres hoping
Overview
Any test facility which conducts, or intends to conduct, regulatory studies must comply with good laboratory practice (GLP) regulations when carrying out safety tests on:
pharmaceuticals
agrochemicals
veterinary medicines
industrial chemicals
cosmetics
additives for human food and animal feed
biocides
The test facility must belong to the UK GLP compliance monitoring programme, run by the UK GLP Monitoring Authority (UK GLPMA). The programme is only open to facilities in the UK.
Test facilities that are contracted to work on part of a larger regulatory study should also usually be members of the compliance programme.
Sad - Read RNS dated 3rd Nov 2021
CEREUSLY £22.50p per share typo me thinks
I noticed on date posted -
1801 clinical stage30 Sep 2022 07:06
Just looked on sareums website pipeline … Proprietary programmes chart tells of 1801 has entered clinical stage.. gla
The market reacted in a positive way- IMO somebody didn’t like that so they blurred the lines until the somebody was happy. 1801 via chart has edged into clinical stage and was reinstated this morning, games being played, ii taking there places. Once everything is in place the green light via more than likely PH will allow information to flow in the public domain. Come on SAR gla
CTA process as far as reading RNSs was carried out by experts in the field. Don’t think failure is an option or else they would not get paid. Well anyway I am an optimist hold for gold gla
It’s this time of year… Surly the price needs to be higher for this to be credible??? Only the BOD know what’s coming?
Wed, 3rd Nov 2021 15:00
RNS Number : 2516R
Sareum Holdings PLC
03 November 2021
Sareum Holdings PLC
("Sareum" or the "Company")
Exercise of Share Options and Director Dealings
Cambridge, UK, 3 November 2021 - Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, announces the following share transactions carried out by certain Directors.
On 3 November 2021, Dr Tim Mitchell (Chief Executive Officer) and Dr John Reader (Chief Scientific Officer) each exercised options over 2,566,666 ordinary shares of 0.025 pence each ("New Ordinary Shares") in the Company (the "Options"), at an exercise price of 1.2 pence per share, for an aggregate consideration of £61,600.
The Options were granted on 13 March 2012, under the Sareum Holdings plc Enterprise Management Incentives Option Agreement, as a key part of the Company's long-term incentive scheme to retain key talent in the business. The Options were due to lapse on 12 March 2022.
Following the exercise of the Options, on 3 November 2021, Dr Mitchell and Dr Reader each agreed to sell all 2,566,666 of the New Ordinary Shares at a price of 6.0 pence per share (the "Share Sale").
Application has been made to the London Stock Exchange for the 5,133,332 new Ordinary Shares to be admitted to trading on AIM ("Admission") and it is expected that Admission will become effective, and trading will commence at 8.00 a.m. on 10 November 2021.
Following Admission, the total number of Ordinary Shares in issue will be 3,370,834,480 and the total number of voting rights will therefore be 3,370,834,480. This figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the share capital of the Company under the FCA's Disclosure and Transparency Rules.
Following the Option exercise and Share Sale, Dr Mitchell's and Dr Reader's resultant interests in the Company will be:
Evening Hot.. Hopefully also seating arrangements for drinky-poohs with golden pens at hand for signing on champagne blurry lines??? Who knows gla
Well Utahsaints you must be pecking in the birdbath fellow as your invested in both woof woof!!!
ABBVIE only have a market cap of $258 billion so let’s hope they got the minerals to buy Sareums Molecules?? Lock stock gla
Well anyway growing excitement would be the evidence of institutional investment of a grand scale this has got to be somewhere close to the bottom should be time to load up??? Maybe hopefully time will tell GLA X
I like it
Dr Tim Mitchell, CEO of Sareum, commented:
"We close this financial year with growing excitement around the potential for our portfolio of differentiated TYK2/JAK1 inhibitors.
"Our lead programme, SDC-1801, is a TYK2/JAK1 inhibitor which we believe has significant potential for superior efficacy in autoimmune disease compared to oral therapies currently available and in development. We have submitted a Clinical Trial Authorisation (CTA) application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and, subject to the required approval, hope to begin clinical trials in healthy volunteers before the end of 2022, with a psoriasis trial planned for 2023. This comes against a background of increased recognition around the potential for the TYK2/JAK1 class, and we have been encouraged by the recent FDA approval of BMS's Sotyktu, the first approved TYK2 therapeutic, and the interest building around the space."
"Our expertise in kinase inhibition, alongside momentum in our translational work, also supports confidence in SDC-1802, our immunotherapy programme targeting cancer. We are working to further define an appropriate patient population for clinical work and look forward to continued progress with this and our other programmes.
"We are pleased to have clarity on SRA737 and to be able to plan the next steps for SRA 737 together with CPF. We continue to believe that SRA737 has great potential for the treatment of cancer, particularly in combination settings."